How Does the FDA Regulate Nutritional Supplements?
Inadequate Food and Drug Administration (FDA) oversight in premarket nutritional supplements and vitamins manufacturing can lead to potentially dangerous products being sold on the marketplace. Research has shown that some supplements and vitamins contain dangerous amounts of potentially harmful agents. For example, one study found some vitamins to contain lead, arsenic, cadmium, and other dangerous metals. Contaminated supplements pose a threat to consumers, putting them at risk of several serious adverse health effects, including death.
Federal law requires that every dietary supplement is labeled, either with the term “dietary supplement” or with a term that substitutes a description of the product’s dietary ingredient(s) for the word “dietary” (e.g., “herbal supplement” or “calcium supplement”).
In general, FDA’s role with a dietary supplement product begins after the product enters the marketplace. That is usually the FDA’s first opportunity to take action against a contaminated supplement or product that presents a significant or unreasonable risk of illness or injury, or that is otherwise adulterated or misbranded.
Federal law does not require dietary supplements to be proven safe to FDA’s satisfaction before they are marketed. For most claims made in the labeling of dietary supplements, the law does not require the manufacturer or seller to prove to the FDA’s satisfaction that the claim is accurate or truthful before it appears on the product.
Once a dietary supplement is available for purchase, the FDA has certain responsibilities. These responsibilities include monitoring mandatory reporting of serious adverse events by dietary supplement firms and voluntary adverse event reporting by consumers and health care professionals. The FDA also reviews product labels and other product information, such as package inserts, accompanying literature, and Internet promotion.
Dietary supplement firms must report to FDA any serious adverse events that are reported to them by consumers or health care professionals. However, dietary supplement manufacturers do not have to get agency approval before producing or selling these products.
There are substantial limitations to FDA oversight of claims in dietary supplement labeling. For example, the FDA reviews claims as resources permit. Under DSHEA, (Dietary Supplement Health and Education Act of 1994) dietary supplements are held to a different standard. Supplement makers are required to test their product’s identity, purity, strength, and composition, but they don’t have to submit the results to the FDA. They also have to notify the agency of new ingredients. But those ingredients are only reviewed for safety and are not subject to any formal stringent approval process.
Part of the problem is a lack of resources within the FDA. Since DSHEA became law, the number of supplement products has grown exponentially from 4,000 in 1994 to more than 90,000 in 2018. The FDA’s budget to monitor supplements hasn’t grown in tandem. The industry currently generates $40 billion a year; the agency’s budget for supplement regulation is but a small fraction of that amount.
To remove a contaminated supplement from the market, the FDA must show that it poses a danger to consumers once it’s already for sale. This duty falls on doctors, consumers, and supplement manufacturers to report any suspected problems. However, doctors often do not initially connect an illness to possibly contaminated supplements. If doctors do connect the illness to contaminated supplements, the doctor might not think to call the FDA. GAO reports found that over one thousand contaminated supplement-related calls were going to poison-control centers rather than to the FDA.